Refractory B-Lineage LeukemiaPhase 1/2NCT02370160
HM2014-26 DT2219 for Relapsed or Refractory B-Lineage Leukemia or Lymphoma
A Phase 1/2 study testing DT2219ARL in people with Refractory B-Lineage Leukemia and Relapsed B-Lineage Leukemia, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
This is a phase I/II study of DT2219 for the treatment of relapsed or refractory CD19 (+) and/or CD 22 (+) B-lineage leukemia and lymphoma. The study consists of two phases - a phase I dose/schedule finding component using the maximum tolerated dose identified during the previous phase I study, but with a higher… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Refractory B-Lineage Leukemia, Relapsed B-Lineage Leukemia, Refractory B-Lineage Lymphoma
- What is being tested?
- DT2219ARL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2015to 8 Apr 2018
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologic verification of B-cell lineage leukemia or B cell non-Hodgkin lymphoma and evidence of relapse/refractory disease with the presence of CD19 and/or CD22 by flow cytometry or immunohistochemistry of bone marrow aspirate, peripheral blood or node/tumor biopsy
- Relapsed refractory disease that has failed conventional therapy and other therapies of higher priority
- Karnofsky Performance status of ≥ 60% or, if less than 16 years of age, Lansky Play Score of ≥ 60 (appendix II)
- Recovered from effects of prior therapy
- Peripheral blast count under 50 x 10^9/L
- Adequate organ function within 14 days (30 days for cardiac and pulmonary) of treatment start
- Women of childbearing potential and men should be advised and agree to practice effective methods of contraception during the course of study
- Voluntary written consent with appropriate parent/guardian consent and minor information sheet for participants < 18 years of age
Who cannot join
- Presence of leukemic or infectious pulmonary parenchymal disease
- Presence of active CNS leukemia
- Presence of any uncontrolled systemic infection
- Documented uncontrolled seizure disorder- a seizure disorder controlled with medication
- Active neurologic disorder - peripheral neuropathy alone does not exclude a patient
- Active Hepatitis B or Hepatitis C (virus detectable by PCR)
- Documented penicillin or cephalosporin allergies
- Pregnant or lactating
Trial locations and contacts
1 site in 1 country.
United States1 site
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: HM2014-26 DT2219 Immunotoxin for the Treatment of Relapsed or Refractory CD19 (+) and/or CD 22 (+) B-lineage Leukemia or Lymphoma
This is a phase I/II study of DT2219 for the treatment of relapsed or refractory CD19 (+) and/or CD 22 (+) B-lineage leukemia and lymphoma. The study consists of two phases - a phase I dose/schedule finding component using the maximum tolerated dose identified during the previous phase I study, but with a higher number of doses and a two-stage phase II extension component to confirm safety and make a preliminary determination of the activity level by disease using the dose identified in phase I.
- Conditions
- Refractory B-Lineage Leukemia, Relapsed B-Lineage Leukemia, Refractory B-Lineage Lymphoma, Relapsed B-Lineage Lymphoma
- Being tested
- DT2219ARL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DT2219ARLBiological
DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| DT2219ARL | Experimental | A recombinant bispecific antibody-targeted toxin. Receives: Biological: DT2219ARL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Incidence of Any DLT Attributed to DT2219 in the First Cycle
Dose limiting toxicity (DLT) is defined as any of the following adverse events occurring from study day 1 through 7 days after the last dose of DT2219 of the 1st treatment cycle, and not clearly attributed to the primary malignancy or intercurrent illness:
- any Grade 5 adverse event
- any Grade 4 neutropenia or thrombocytopenia lasting more for than 7 days
- any Grade 3 thrombocytopenia with bleeding
- any Grade 4 non-hematologic adverse event during DT2219 infusion
- any Grade 3 non-hematologic adverse event occurring after completion of DT2219 infusion
Measured: Day 1 - Day 29
Phase ll: Overall Disease Response
Response is defined as complete response, partial response and stable disease. Complete response is defined as the disappearance of all signs of cancer in response to treatment. This does not always mean the cancer has been cured.
Partial response is defined as a decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment.
Stable disease is defined as cancer that is neither decreasing nor increasing in extent or severity.
Measured: Day 29
Secondary outcomes (5)
Incidence of Serious Adverse Events
A Serious Adverse Event is defined as an adverse event that results in any of the following outcomes:
- Death
- A life-threatening adverse event
- Inpatient hospitalization or prolongation of existing hospitalization
- A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
- A congenital anomaly/birth defect.
- Important medical event
Measured: Day 29
Phase II : Duration of Response
Duration of response was calculated as duration between on-study date and best response date for those patients who achieved complete remission (CR) or partial response (PR)
Measured: 1 year
Disease-free Survival
Measured: 1 year
Overall Survival
Measured: 1 year
Time to Relapse/Progression
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2015 (estimated)
- Study start21 Dec 2015
- Primary completion8 Apr 2018
- Study completion8 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Refractory B-Lineage LeukemiaStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Veronika Bachanova, MD, PhD, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02370160
- Sponsor's protocol ID
- 2014LS093
- Status last verified
- Dec 2019
- First submitted
- 18 Feb 2015
- Last updated
- 13 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HM2014-26 DT2219 Immunotoxin for the Treatment of Relapsed or Refractory CD19 (+) and/or CD 22 (+) B-lineage Leukemia or Lymphoma
- ClinicalTrials.gov ID
- NCT02370160
- Acronym / sponsor ID
- 2014LS093
- Conditions
- Refractory B-Lineage Leukemia, Relapsed B-Lineage Leukemia, Refractory B-Lineage Lymphoma, Relapsed B-Lineage Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- 21 Dec 2015 (actual)
- Primary completion
- 8 Apr 2018 (actual)
- Study completion
- 8 Apr 2018 (actual)
- First posted
- 24 Feb 2015 (estimated)
- Results
- Posted 13 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase I/II study of DT2219 for the treatment of relapsed or refractory CD19 (+) and/or CD 22 (+) B-lineage leukemia and lymphoma. The study consists of two phases - a phase I dose/schedule finding component using the maximum tolerated dose identified during the previous phase I study, but with a higher number of doses and a two-stage phase II extension component to confirm safety and make a preliminary determination of the activity level by disease using the dose identified in phase I.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DT2219ARL | Experimental | Biological: DT2219ARLA recombinant bispecific antibody-targeted toxin. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Histologic verification of B-cell lineage leukemia or B cell non-Hodgkin lymphoma and evidence of relapse/refractory disease with the presence of CD19 and/or CD22 by flow cytometry or immunohistochemistry of bone marrow aspirate, peripheral blood or node/tumor biopsy
- Relapsed refractory disease that has failed conventional therapy and other therapies of higher priority
- Karnofsky Performance status of ≥ 60% or, if less than 16 years of age, Lansky Play Score of ≥ 60 (appendix II)
- Recovered from effects of prior therapy
- Peripheral blast count under 50 x 10^9/L
Key exclusion criteria (8 listed)
- Presence of leukemic or infectious pulmonary parenchymal disease
- Presence of active CNS leukemia
- Presence of any uncontrolled systemic infection
- Documented uncontrolled seizure disorder- a seizure disorder controlled with medication
- Active neurologic disorder - peripheral neuropathy alone does not exclude a patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DT2219ARLDT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity. | Biological | DT2219ARL |
Primary outcome
Phase I: Incidence of Any DLT Attributed to DT2219 in the First Cycle
Time frame: Day 1 - Day 29
Dose limiting toxicity (DLT) is defined as any of the following adverse events occurring from study day 1 through 7 days after the last dose of DT2219 of the 1st treatment cycle, and not clearly attributed to the primary malignancy or intercurrent illness: * any Grade 5 adverse event * any Grade 4 neutropenia or thrombocytopenia lasting more for than 7 days * any Grade 3 thrombocytopenia with bleeding * any Grade 4 non-hematologic adverse event during DT2219 infusion * any Grade 3 non-hematologic adverse event occurring after completion of DT2219 infusion
Phase ll: Overall Disease Response
Time frame: Day 29
Response is defined as complete response, partial response and stable disease. Complete response is defined as the disappearance of all signs of cancer in response to treatment. This does not always mean the cancer has been cured. Partial response is defined as a decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment. Stable disease is defined as cancer that is neither decreasing nor increasing in extent or severity.
5 secondary outcomes
Incidence of Serious Adverse Events
Time frame: Day 29
Phase II : Duration of Response
Time frame: 1 year
Disease-free Survival
Time frame: 1 year
Overall Survival
Time frame: 1 year
Time to Relapse/Progression
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Refractory B-Lineage Leukemia
RecruitingPhase 2
Inotuzumab Ozogamicin and Blinatumomab With or Without Ponatinib in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia
B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative, Recurrent B Acute Lymphoblastic Leukemia
RecruitingPhase 1
Trivalent CAR-T Cell in Acute B-Lineage Leukemia (TRICAR-ALL)
Leukemia, B-Cell
Active, not recruitingPhase 2
A Study of Revumenib in Combination With Chemotherapy for Patients Diagnosed With Relapsed or Refractory Leukemia
Recurrent Acute Leukemia of Ambiguous Lineage, Recurrent Acute Lymphoblastic Leukemia
Active, not recruitingPhase 1
Genetically Modified T-cell Infusion Following Peripheral Blood Stem Cell Transplant in Treating Patients With Recurrent or High-Risk Non-Hodgkin Lymphoma
Adult Grade III Lymphomatoid Granulomatosis, Cutaneous B-cell Non-Hodgkin Lymphoma
RecruitingPhase 1/2
Co-administration of CART22-65s and huCART19 for B-ALL
B-cell Acute Lymphoblastic Leukemia, B Lineage Lymphoblastic Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veronika Bachanova, MD, PhD principal investigator
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DT2219ARL in people with Refractory B-Lineage Leukemia and Relapsed B-Lineage Leukemia, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: Incidence of Any DLT Attributed to DT2219 in the First Cycle (time frame: Day 1 - Day 29). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.